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Efficacy of Cardioviva™ Probiotic Yogurt Formulation

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Cardioviva™ yogurt

Placebo yogurt

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring yogurt, probiotic, cholesterol

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy males and females.
Aged 18-74 years old.
Low Density Lipoprotein (LDL-C) above 3.4 mmol/L (<15% variation between visits V1 and V2-1).
Triglyceride (TG) levels below 4.0 mmol/l (check at V0 and V2-1).
Body Mass Index (BMI) range was 22 to 32 kg/m2.
Ability to understand dietary procedures.
Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated.
Signed informed consent form prior to inclusion in the study
Note: Subjects were permitted to take stable doses of thyroid hormone, anti-hypertensive agents, and contraceptive hormones (e.g. contraceptive pills or patches), as long as these were continued equivalently throughout the duration of study.

Exclusion Criteria:

Use of statin or other cholesterol lowering prescription drugs within the last 6 months.
Use of plant sterols, omega-3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription supplements within last 3 months.
History of chronic use of alcohol (>2 drinks/day).
Use of systemic antibodies, corticosteroids, androgens, or phenytoin.
Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
Lactose intolerance or allergies to dairy products.
History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
Chronic user of probiotics or fiber laxative (greater than 2 doses/week), or stimulant laxatives.
History of eating disorders.
Exercise greater than 15 miles/week or 4,000 kcal/week.
Pregnancy, breast feeding, or intent to get pregnant.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Cardioviva™ yogurt

Placebo yogurt

Arm Description

Outcomes

Primary Outcome Measures

The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)

Secondary Outcome Measures

Full Information

NCT ID

NCT01185795

First Posted

August 18, 2010

Last Updated

June 29, 2012

Sponsor

Micropharma Limited

1. Study Identification

Unique Protocol Identification Number

NCT01185795

Brief Title

Efficacy of Cardioviva™ Probiotic Yogurt Formulation

Official Title

Efficacy of a Microencapsulated Probiotic Yogurt Formulation as a Health Promoting Agent

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Micropharma Limited

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Background: Several studies have reported limited or no reduction in serum lipid concentrations in response to probiotic formulations. More recently, probiotics have shown promise in treating metabolic disease, due to improved strain selection and delivery technologies. Objective: To evaluate the lipid lowering efficacy of a yogurt formulation containing microencapsulated Bile Salt Hydrolase (BSH)-active Lactobacillus reuteri cardioviva, taken twice per day over 6 weeks, in subjects with hypercholesterolemia. Design: This is a double-blinded, multi-centric, placebo-controlled, randomized, parallel-arm study. The study will last a total of 10 weeks including 2-week wash-out, 2-week run-in, and 6- week treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

Keywords

yogurt, probiotic, cholesterol

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardioviva™ yogurt

Arm Type

Experimental

Arm Title

Placebo yogurt

Arm Type

Placebo Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Cardioviva™ yogurt

Intervention Description

L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo yogurt

Intervention Description

yogurt, twice per day (BID), 6 weeks

Primary Outcome Measure Information:

Title

The primary outcome variable will be the percent change from baseline in Low Density Lipoprotein Cholesterol (LDL-C)

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males and females. Aged 18-74 years old. Low Density Lipoprotein (LDL-C) above 3.4 mmol/L (<15% variation between visits V1 and V2-1). Triglyceride (TG) levels below 4.0 mmol/l (check at V0 and V2-1). Body Mass Index (BMI) range was 22 to 32 kg/m2. Ability to understand dietary procedures. Judged by the investigators as compliant (>80%) with product consumption (check at V2-1), and motivated. Signed informed consent form prior to inclusion in the study Note: Subjects were permitted to take stable doses of thyroid hormone, anti-hypertensive agents, and contraceptive hormones (e.g. contraceptive pills or patches), as long as these were continued equivalently throughout the duration of study. Exclusion Criteria: Use of statin or other cholesterol lowering prescription drugs within the last 6 months. Use of plant sterols, omega-3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription supplements within last 3 months. History of chronic use of alcohol (>2 drinks/day). Use of systemic antibodies, corticosteroids, androgens, or phenytoin. Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months. Lactose intolerance or allergies to dairy products. History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year). Chronic user of probiotics or fiber laxative (greater than 2 doses/week), or stimulant laxatives. History of eating disorders. Exercise greater than 15 miles/week or 4,000 kcal/week. Pregnancy, breast feeding, or intent to get pregnant.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell L Jones, MD, MEng

Organizational Affiliation

Micropharma Limited

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Cardioviva™ Probiotic Yogurt Formulation

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